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MDA · Import permit · Enforcement 1 July 2027

The import permit deadline moved. Most guides still have the old date.

MDA postponed medical device import permit enforcement from 2 January 2026 to 1 July 2027. Existing customs procedures continue until then — but the permit is coming, and the licensing work it assumes takes longer than the notice period.

Establishment licence service
01 MDA Registration02 GDPMD + Licensing03 ISO 13485 QMS04 MDSAP05 CE / FDA Export
The correction

2 January 2026 is no longer the date.

In an announcement dated 1 December 2025, the Medical Device Authority confirmed that the enforcement date for the medical device import permit, originally set for 2 January 2026, has been postponed to 1 July 2027. Until then, in MDA's own words, importation of medical devices continues to follow the existing import procedures for customs declaration purposes.

We are flagging this prominently because a large amount of consultancy and trade-press guidance published during 2025 still states the January 2026 date as current. If you have an internal compliance calendar built on that date, it is wrong in both directions: you are not late, and you have more runway than you think — but the runway is for work most importers have not started.

The timeline as it actually stands

DateWhat happensStatus
2 January 2026Original enforcement date for the import permitSuperseded
1 June 2026Voluntary Verification Slip applications open for non-medical devices under medical device tariff codesVoluntary
Now → 30 June 2027Existing customs import procedures continue to applyCurrent state
1 July 2027Import permit enforcement beginsEnforcement

How the permit will work

The legal basis is the Customs (Prohibition of Import) Order 2023, which makes importation of medical devices subject to an import permit. This is customs law running alongside Act 737 — a second, independent control on the same shipment. Applications are lodged through the ePermit system at newepermit.dagangnet.com.my. MDA's published operating parameters:

  • RM130 per application, with a waiver available for eligible importers during the transition.
  • Apply at least 7 days before shipment.
  • Processed within 3 working days upon confirmation of payment.
  • Expedited to within 24 hours for urgent shipments — MDA cites overnight road shipments from Singapore or Thailand, and temperature-sensitive goods.

Three approvals, three levels — do not confuse them

Every week we take a call from an importer who believes one of these covers the others. None of them do.

ApprovalLevelLegal basisCovers
Establishment licenceBusinessAct 737Your company's right to import or distribute at all
Device registrationProductAct 737That specific device being legal on the Malaysian market
Import permitShipmentCustoms (Prohibition of Import) Order 2023That specific consignment clearing customs

The permit is an additional import control, not a replacement for product registration. When enforcement starts, a shipment needs all three to move.

What to do with the extra eighteen months

  1. Fix the business layer first. An establishment licence with GDPMD certification takes months, not weeks, and everything else assumes it exists. Packages from RM18,000, all-inclusive.
  2. Audit your registrations against what you actually ship. Product ranges drift. Variants get added. Permit enforcement is a per-shipment check, which is exactly the mechanism that surfaces an unregistered variant you have been importing for two years.
  3. Reconcile tariff codes. The 1 June 2026 voluntary phase exists because non-medical goods sitting under medical device tariff codes are a real and common problem. Test yours while a mistake is free.
  4. Create and test ePermit accounts. Account activation and user roles are administrative, tedious, and disastrous to discover on the day a temperature-sensitive shipment is waiting.
Jawapan ringkas · Bahasa Malaysia

Adakah permit import peranti perubatan sudah wajib?

Belum. MDA telah menangguhkan penguatkuasaan permit import dari 2 Januari 2026 kepada 1 Julai 2027 (pengumuman bertarikh 1 Disember 2025). Sementara itu, prosedur import sedia ada diteruskan. Permit ini adalah kawalan tambahan di peringkat penghantaran — ia tidak menggantikan pendaftaran produk atau lesen establishmen. WhatsApp 010-206 2070 untuk semakan kesediaan.

FAQ

Frequently asked questions

Is the medical device import permit required now?
No. MDA postponed enforcement from 2 January 2026 to 1 July 2027 in an announcement dated 1 December 2025. Until that date, importation of medical devices continues to follow the existing import procedures for customs declaration purposes. A great deal of guidance published in 2025 still says 2 January 2026 — that date is superseded.
What happens on 1 June 2026?
That is the start of a voluntary phase, not enforcement. From 1 June 2026 stakeholders may voluntarily submit Verification Slip applications for non-medical devices that fall under medical device tariff codes — the goods-classification edge case that causes most customs disputes. Using it early is how you find out your tariff code is wrong before it is expensive.
What is the legal basis for the permit?
The Customs (Prohibition of Import) Order 2023 makes importation of medical devices subject to an import permit. That is customs law working alongside the Medical Device Act 2012 (Act 737) — two separate controls, two separate consequences for getting them wrong.
Does an import permit replace device registration?
No, and treating it as a substitute is the expensive mistake. The permit is a shipment-level customs authorization. Registration under Act 737 is a product-level approval, and an establishment licence is a business-level approval. You need all three: a permit will not legalise an unregistered device, and a registration will not clear a shipment once permits are enforced.
How much does an import permit cost and how long does it take?
MDA states RM130 per application, processed within 3 working days upon confirmation of payment. For urgent shipments — MDA gives overnight road shipments from Singapore or Thailand and temperature-sensitive goods as examples — the Authority may expedite to within 24 hours upon confirmation of payment.
How far in advance do we apply?
MDA states that applications may be submitted at least 7 days prior to shipment. Applications go through the ePermit system at newepermit.dagangnet.com.my, which is the same DagangNet infrastructure used for other Malaysian import permits.
What should importers do with the extra time?
Three things, in this order. Get the establishment licence and GDPMD in place if they are not already — that is months of work and it gates everything. Confirm every product is correctly registered and that your tariff codes match what you actually import. Then get ePermit accounts and user roles created and tested during the voluntary phase, so 1 July 2027 is an administrative date rather than a shipping crisis.
Does the postponement affect the tender rules or anything else?
No. The postponement is specific to the import permit. Circular Letter No. 1/2026, in force since 28 January 2026, still requires a valid MDA establishment licence before participating in any new medical device tender. Those are unrelated obligations on unrelated timelines.

Importing medical devices into Malaysia?

The permit deadline moved, but the licensing work behind it did not get shorter. Send us what you import and we will tell you what is missing before it becomes a customs problem.

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